Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel [21 CFR 211.68(b)]. Specifically,
There was a failure to validate the [redacted] software to assure that all data generated by the system was secure. This software runs the laboratory HPLC equipment, generates and stores data, and performs calculations during testing of raw materials, in-process materials, finished products, and stability samples.
User access levels for the [redacted] software were not established and documented. Currently, laboratory personnel use a common password to gain access to the system and there are no user access level restrictions for deleting or modifying data. Furthermore, your system does not have an audit trail to document changes.